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Trial Title:
SHR1701 Alone or in Combination With SHR2554 in Relapsed or Refractory Classical Hodgkin Lymphoma
NCT ID:
NCT05896046
Condition:
Relapsed or Refractory Hodgkin Lymphoma
Conditions: Official terms:
Lymphoma
Hodgkin Disease
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SHR2554+ SHR1701
Description:
SHR2554: 350mg/day, PO, twice a day. SHR1701: recommended dose from phase I trial, IV,
over 30 minutes.
Arm group label:
Phase II: SHR2554+ SHR170
Intervention type:
Drug
Intervention name:
SHR-1701
Description:
Phase I: 30-150 mg/kg, IV over 30 minutes. Phase II: recommended dose from phase I trial,
IV over 30 minutes.
Arm group label:
Phase I/ II: SHR1701
Summary:
This is an open-label, phase I/II dose escalation and expansion trial. The primary
objective of dose escalation phase I study is to evaluate the safety and feasibility of
SHR1701 in patients with relapsed or refractory classical Hodgkin Lymphoma. The primary
objective of open-label, randomized, phase II study is to assess the antitumor effect of
SHR1701 alone or in combination with SHR2554 in patients with relapsed or refractory
classical Hodgkin Lymphoma.
Detailed description:
In phase I study, patients received intravenous SHR1701 30-150 mg/kg every 3 weeks.
Sequential patient groups received the following doses of SHR1701: 30 mg/kg, 60 mg/kg, 90
mg/kg, 120 mg/kg, or 150 mg/kg in a 3+3 design with the intention of determining the
recommended dose for phase 2. Toxicities are graded according to the Common Terminology
Criteria for Adverse Events, version 5.0.
In phase II expansion study, based on the recommended dose of SHR1701 from phase I study,
patients are treated with SHR1701 alone if CR rate is satisfactory, or randomized to
SHR1701 monotherapy group or SHR2554 plus SHR1701 combination group to assess the
clinical efficacy of SHR2554 plus SHR1701 combination therapy.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Subjects must have histological confirmation of relapsed or refractory Hodgkin
lymphoma (HL).
2. 12 to 75 years of age.
3. ECOG performance of less than 2.
4. Life expectancy of at least 3 months.
5. Subjects with lymphoma must have at least one measureable lesion >1 cm as defined by
lymphoma response criteria.
6. Subjects must have received two or more lines of previous therapy, and must be off
therapy for at least 4 weeks prior to Day 1. Subjects with autologous hematopoietic
stem-cell transplantation are eligible which must be more than 3 months. Previous
treatment with anti-PD-1/PD-L1 antibodies or cytotoxic T lymphocyte associated
antigen 4 (CTLA-4) inhibitors are allowed, and must be off therapy for at least 4
weeks.
7. Subjects must have adequate marrow, live, renal and heart functions.
Exclusion Criteria:
1. Subjects with any autoimmune disease or history of syndrome that requires
corticosteroids or immunosuppressive medications.
2. Serious uncontrolled medical disorders or active infections, pulmonary infection
especially.
3. Active alimentary tract hemorrhage or history of alimentary tract hemorrhage in 1
month .
4. Prior organ allograft.
5. Women who are pregnant or breastfeeding.
6. Women with a positive pregnancy test on enrollment or prior to investigational
product administration.
7. Subjects who are compulsorily detained for treatment of either a psychiatric or
physical (eg, infectious disease) illness.
Gender:
All
Minimum age:
12 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Han wei dong
Address:
City:
Beijing
Zip:
100853
Country:
China
Status:
Recruiting
Contact:
Last name:
Han W dong
Phone:
+861055499341
Email:
hanwdrsw@sina.com
Start date:
June 14, 2023
Completion date:
June 1, 2026
Lead sponsor:
Agency:
Chinese PLA General Hospital
Agency class:
Other
Source:
Chinese PLA General Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05896046
